Effect of Interceptive Strategies on the Clinical Outcome of Maxillary Impacted Canines

This study aims to investigate the effect of 3 randomly applied interceptive measures (slow maxillary expansion, extraction of deciduous canines and no intervention) on maxillary canine impaction in patients with early mixed dentition and lack of space in the dental arch. Additionally, these groups are compared with a control group with adequate space. Patients with at least one impacted maxillary canine, presence of deciduous canines and absence of crossbite were included. The canine position is assessed by measuring five variables (sector of the canine cusp, canine to midline angle, canine to first premolar angle, canine cusp to midline distance, and canine cusp to maxillary plane distance) on 2 panoramic radiographs at 0 (T1) and 18 months (T2).

Study Overview

• Status: Completed
• Conditions: Tooth, Impacted
• Intervention / Treatment: Procedure: Maxillary expansion; Procedure: Extraction of deciduous upper canines

Detailed Description

The detailed information regarding methodology has been entered in following sections

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 7 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All patients presenting at the intake consultation of the Department of Orthodontics of University Hospitals Leuven, Belgium from September 2016, with at least one maxillary permanent canine impaction are invited to participate. Canine impaction is diagnosed based on a panoramic radiograph, taken for standard evaluation of dental development and associated pathology. A maxillary canine is considered to be impacted when the canine to midline angle was ≥15° (Alqerban et al. 2014; Warford et al. 2003). Only impacted maxillary canines with incomplete root formation and with persisting deciduous canines are included.

Exclusion Criteria:

• presence of uni- or bilateral posterior dental crossbite,
• upper permanent canines showing root malformation, ankylosis or fully erupted,
• evidence of root resorption of adjacent teeth, previous orthodontic treatment,
• craniofacial syndromes,
• systemic disease that would impede orthodontic treatment/surgery and recent exposure to radiotherapy.
• large eruption follicles seen on the permanent canines

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Maxillary expansion; All included patients (in all arms) present (at least one) maxillary canine impaction. Patients in this arm present also lack of space in the upper jaw and are treated with maxillary expansion	Procedure: Maxillary expansion; The upper jaw is expanded with a removable expansion plate
Experimental: Extraction of deciduous canines; All included patients (in all arms) present (at least one) maxillary canine impaction. Patients in this arm present also lack of space in the upper jaw and are treated with extraction of deciduous canines	Procedure: Extraction of deciduous upper canines; Both deciduous upper canines are extracted in this group
No Intervention: No intervention; All included patients (in all arms) present (at least one) maxillary canine impaction. Patients in this arm present also lack of space in the upper jaw and no intervention is performed
No Intervention: Control; All included patients (in all arms) present (at least one) maxillary canine impaction. Patients in this arm do not present lack of space in the upper jaw and no intervention is performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Definitive Upper Canines That Erupt Spontaneously up to 18 Months of Follow up	Number of definitive upper canines that erupt spontaneously up to 18 months of follow up.	18 months
Number of Definitive Upper Canines That Erupt Spontaneously After 18 Months of Follow up	Number of definitive upper canines that erupt spontaneously after 18 months of follow up..	After the first 18 months of follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sector Where the Canine is Located	The sector is the position where the canine overlaps with adjacent teeth in a panoramic radiograph. The distance between the dental midline and the premolars is divided in 5 equally large spaces (units or categories 0 to 4) defined as follows: 0 = normal position (the cusp of the definitive canine is at the primary canine), 1 = distal to the long axis of the lateral incisor, 2 = mesial to the long axis of the lateral incisor, 3 = distal to the long axis of the central incisor, or 4 = mesial to the long axis of the central incisor This outcome measurement refers to the change in the Sector category where the canine is located, measured on a panoramic RX	18 months
Angulation of the Canine Towards the Dental Midline	Change in the Angulation of the canine towards the dental midline, measured on a panoramic RX	18 months
Angulation of the Canine Towards the First Premolar	Change in the Angulation of the canine towards the first premolar	18 months
Distance Between the Canine Cusp and the Midline	Change in the Distance between the canine cusp and the midline	18 months
Distance Between the Canine Cusp and the Occlusal Plane	Chenge in the Distance between the canine cusp and the occlusal plane, measured on a	18 months
Need for Further Minor and/or Major Orthodontic Intervention	Need for further minor and/or major orthodontic interventions	18 months after baseline

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Maria Cadenas, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2016
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Estimated): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Tooth extraction; maxillary expansion; deciduous tooth; Interceptive orthodontics; maxillary canines
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted
• Other Study ID Numbers: S59030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No